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[Changes in the norms governing practices for the manufacture of pharmaceutical products: implications for the
G Temprano1, S Prats, C Bregni
1Departamento de Tecnología Farmacéutica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Argentina.
Abstract:
It is done a comparative study between the "Recommended rules for drug products manufacturing and inspection", approved in 1975 by the World Health Organization (and still in force in the MERCOSUR); and the standards published in 1992 by the WHO Expert Committee on Specifications for Pharmaceutical Preparations 32nd Report, named "Good Manufacturing Practices for pharmaceutical products". The correspondence between the regulation in force in the MERCOSUR and the Good Manufacturing Practices Inspection Guide for pharmaceutical industry, used by Health Authorities in the Common Market Member States, is analysed. It is noticed a disagreement between the rule in force and the instrument for verifying its fulfillment. The proposal of this article is the adoption by the Common Market Group, of the rules published by the WHO in 1992, and the establishment of an inspection guide which absolute agrees with it.